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FDA 510(k)

HEM-O-LOK(TM)

K-Number: K902108 · 1990-08-06

ApplicantEdward Weck, Inc.
Decision Date1990-08-06
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEM-O-LOK(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1990-08-06 under 510(k) number K902108. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEM-O-LOK(TM)?

HEM-O-LOK(TM) is a medical device that received FDA 510(k) clearance on 1990-08-06. The listed applicant is Edward Weck, Inc.. The 510(k) number is K902108.

When did HEM-O-LOK(TM) receive FDA 510(k) clearance?

HEM-O-LOK(TM) received FDA 510(k) clearance on 1990-08-06, under 510(k) number K902108.

Who is the listed applicant for HEM-O-LOK(TM)?

The FDA 510(k) record lists Edward Weck, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEM-O-LOK(TM)?

The FDA product code for HEM-O-LOK(TM) is FZP.

Other records listing Edward Weck, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902232WECK ELECTROSURGICAL GENERATOR #174200

View all 140 devices →

Related Devices (Code: FZP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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